It was reported that a day after the patient¿s device was implanted, she used an electromagnetic therapy device close to her chest for wound treatment for 4 days.
Two day¿s after she started using the device, she experienced a burning sensation in her abdomen.
Approximately a month later, the patient had a tingling sensation in her arm, which got worse about a week later.
Reprogramming was performed several times but the cause of the event was unknown.
The patient was hospitalized for treatment.
As of (b)(6) 2014, the patient still experienced tingling sensations and felt weak.
It was unknown if the patient was receiving effective therapy.
If additional information becomes available, a supplemental report will be submitted.